80318 Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices 

has verified the applicant’s claims that 

the new drug application (NDA) for 

ROZLYTREK CAPSULES (NDA 212726) 

was initially submitted on December 18, 

2018.’’ 

Dated: November 14, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–25489 Filed 11–16–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Scientific 

Registry of Transplant Recipients 

Information Collection Effort for 

Potential Donors for Living Organ 

Donation, OMB No. 0906–0034— 

Extension 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than January 16, 2024. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N39, 5600 Fishers 

Lane, Rockville, Maryland 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Joella Roland, the HRSA 

Information Collection Clearance 

Officer, at (301) 945–0232. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

Scientific Registry of Transplant 

Recipients Information Collection Effort 

for Potential Donors for Living Organ 

Donation, OMB No. 0906–0034— 

Extension. 

Abstract: The Scientific Registry of 

Transplant Recipients (SRTR) is 

administered under contract with 

HRSA, an agency within HHS. HHS is 

authorized to establish and maintain 

mechanisms to evaluate the long-term 

effects associated with living organ 

donations (42 U.S.C. 273a) and is 

required to submit to Congress an 

annual report on the long-term health 

effects of living donation (42 U.S.C. 

273b). In 2018, the SRTR contractor 

implemented a pilot living donor 

registry in which transplant programs 

registered all potential living organ 

donors who provided informed consent 

to participate in the pilot registry. The 

Organ Procurement and Transplantation 

Network final rule, 42 CFR part 121, 

requires organ procurement 

organizations and transplant hospitals, 

‘‘as specified from time to time by the 

Secretary,’’ to submit to the SRTR, as 

appropriate, information regarding 

‘‘donors of organs’’ and ‘‘other 

information that the Secretary deems 

appropriate.’’ 42 CFR 121.11(b)(2). 

In 2018, a pilot living donor registry 

was implemented by the SRTR, and 

each participating transplant program 

registered all potential candidates for 

living donation who provided informed 

consent to enroll. In 2019, an updated 

version of the data collection instrument 

was approved, followed by the latest 

data collection forms which were 

approved on February 26, 2021. These 

data collection modifications were 

intended to improve the quality of the 

data and reduce the administrative 

burden for respondents. This Federal 

Register notice requests an extension of 

the last approved data collection forms 

(February 2021) with no changes to the 

total estimated annualized burden 

hours. 

Need and Proposed Use of the 

Information: The transplant programs 

submit health information collected at 

the time of donation evaluation through 

a secure web-based data collection tool 

developed by the SRTR contractor. The 

SRTR contractor maintains contact with 

registry participants and collects data on 

long-term health outcomes through 

surveys. The data collection includes 

outcomes of evaluation, including 

reasons for non-donation. The living 

donor registry is an ongoing effort, and 

the goal is to continue to collect data on 

living organ donor transplant programs 

in the United States over time. 

Monitoring and reporting of long-term 

health outcomes of living organ donors 

post-donation will continue to provide 

useful information to transplant 

programs for their future donor 

selection process and to aid potential 

living organ donors in their decision to 

pursue living donation. 

Likely Respondents: Potential and 

actual living donors, transplant 

programs, medical and scientific 

organizations, and public organizations, 

including patient advocacy groups. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Average 

number of 

responses per 

respondent 

Total 

number of 

responses 

Average 

burden per 

response 

(in minutes) 

Total 

burden 

hours 

Potential Living Donor Registration form ............................................. a 16 112 1,792 0.27 484 

Potential Living Donor Follow-up form ................................................ b 754 1 754 0.50 377 

Reasons Did not Donate form (liver or kidney) ................................... a 16 106 1,696 0.23 390 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices 80319 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Form name Number of 

respondents 

Average 

number of 

responses per 

respondent 

Total 

number of 

responses 

Average 

burden per 

response 

(in minutes) 

Total 

burden 

hours 

Total .............................................................................................. 786 ........................ 4,242 ........................ 1,251 

a Number of respondents is based on the current number of transplant programs and is likely to increase as additional programs decide to participate. b Number of living organ donor candidates submitting follow-up forms in 2019. 

HRSA specifically requests comments 

on (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2023–25368 Filed 11–16–23; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Announcement of Intent To Establish 

Federal Advisory Committee on Long 

COVID 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services announces the intent to 

establish an Advisory Committee on 

Long COVID and invites nominations 

for the Committee. 

DATES: Nominations must be submitted 

by 11:59 p.m. eastern time on January 

16, 2024. 

ADDRESSES: Nominations may be 

submitted by email to LongCOVID@

hhs.gov and addressed to Allison 

O’Donnell. 202–690–7694. 

FOR FURTHER INFORMATION CONTACT: 

Allison O’Donnell at 202–690–7694 or 

LongCOVID@hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Committee is authorized under 42 

U.S.C. 217a, section 222 of the Public 

Health Service Act, as amended. The 

Committee is governed by the 

provisions of the Federal Advisory 

Committee Act, Public Law 92–463, as 

amended (5 U.S.C. chapter 10), which 

sets forth standards for the formation 

and use of advisory committees. 

The April 5, 2022, Memorandum 

(https://www.whitehouse.gov/briefingroom/presidential-actions/2022/04/05/ 

memorandum-on-addressing-the-longterm-effects-of-covid-19/) on Addressing 

the Long-term Effects of COVID–19 

charged the Secretary of Health and 

Human Services (Secretary) with 

coordinating a Government-wide 

response to the longer-term effects of 

COVID–19. The Secretary named the 

Assistant Secretary for Health to 

coordinate the U.S. Government 

response to Long COVID. The 

Memorandum specified development 

and publication of two reports that were 

published August 3, 2022. One of the 

reports, the National Research Action 

Plan on Long COVID (https://

www.covid.gov/assets/files/NationalResearch-Action-Plan-on-Long-COVID08012022.pdf), called for the 

establishment of a Secretary’s Advisory 

Committee on Long COVID. The 

Committee will bring perspectives from 

outside the Government to help inform 

action of the Executive Branch on Long 

COVID and associated conditions, with 

a focus on health equity. Numerous 

entities across the U.S. Government 

fund and conduct research and use 

external advisory bodies. This Federal 

Advisory Committee does not replace or 

supersede the ongoing work of these 

advisory bodies. 

Structure: The Committee will consist 

of up to 20 members, including any 

Chair, Vice Chair, or Co-Chairs. Factors 

to be considered in selecting individuals 

to serve on the Committee include 

expertise in the issues to be examined 

by the Committee, as well as statutory 

obligations under FACA and desire for 

a balanced and diverse membership. To 

the extent possible, composition of the 

Committee will reflect the experience of 

an inclusive and diverse cross-section of 

persons with Long COVID and 

multidisciplinary expertise of those 

supporting and caring for those affected 

as well as specific clinical, medical, 

public health, behavioral health, human 

services, employment, data science, and 

research expertise. The membership of 

the Committee will reflect diverse 

individuals or organizations including 

underserved populations, with a focus 

on health equity. 

The following areas of expertise will 

be considered in selecting the voting 

members with the goal of achieving a 

balanced membership in terms of points 

of view, expertise, and groups 

represented and functions to be 

performed by the Committee. 

Long COVID and related groups: 

Representation from individuals living 

with Long COVID and organizations 

directly engaged in supporting people 

living with Long COVID. 

Professional Associations: 

Representation from medical 

professional, behavioral health and 

human services associations 

representing practitioners caring for 

people with Long COVID, including 

those representing the primary 

healthcare system. 

Disability and Chronic Illness Groups: 

Representation from associations, 

researchers, or organizations focused on 

disability and chronic illness, and their 

possible interplay with Long COVID. 

Public Health and related groups: 

Representation from public health 

groups supporting communities in 

addressing the impacts of Long COVID. 

Healthcare and Social Care Providers: 

Clinical care settings and health systems 

involved in providing care for patients 

with Long COVID, including in 

underserved areas, such as rural 

communities and communities 

disproportionately impacted by Long 

COVID. 

Employee and Employer Related 

Groups: Representation from employee 

and employer experts, attorneys, or 

organizations involved in addressing the 

impacts of Long COVID in the 

workplace, including discrimination. 

Research: Researchers and research 

institutions involved in Long COVID 

and associated conditions research. 

Non-voting Industry Representatives: 

Those involved in, or representing those 

involved in, Long COVID research and 

development, including prevention, 

diagnostics, and treatment will be 

designated to represent the interests of 

this sector. 


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